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Thursday, December 7, 2006 12:00 AM

Glaxo's guinea pigs

The pharma giant is accused of putting pregnant women at risk in unethical drug trials.

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Thursday, December 7, 2006 08:30 AM

AZT Nonsense

Just so you'll know, AZT has been shown to cause spontaneous abortion in pregnant women, among other grisly results, so the placebo group may actually do better than the drug-taking group. That Glaxo would actually conduct such a study is puzzling, however; since the mid-'90s non-placebo studies have been allowed on pregnant women in Third World countries. This, by the way, apparently violates the Nuremberg Code's prohibition of studies conducted without "informed consent," because none of these subjects would have been informed of the risks of AZT or the uncertainties of current knowledge on HIV, including whether its presence actually leads to illness in newborns.

If the company is indeed carrying out these trials with placebo controls, and finishes them, they would be the first. The original studies leading to the 1987 approval of AZT for use in the U.S. became unblinded and quickly abandoned the placebo controls. The warning label on AZT, which I assume none of the pregnant women in Africa are presumably going to see, has a skull and crossbones on it -- meaning, this stuff is highly toxic. It's still being tested on patients out here in the real world because it was not adequately tested before approval. Nonetheless, it is illegal for mothers in the U.S. to refuse treatment by this drug and other HIV "antivirals" (a misnomer, because there is no proof that they actually kill any live virus; they kill cells). Many women have left the country to avoid this mandatory care.

So now you know.

Undoubtedly, the women in the control group in this African study you mention will do better than the women in the drug-taking group. When this happens, the study will be suppressed, never published, and phone calls seeking information about it -- assuming anyone knows about it -- will not be returned. This is standard practice in AIDS research, and suppression of unfavorable studies is allowed under FDA rules.

See Harper's, March 2006, "Out of Control," for further information on Nevirapine trials in Uganda. Pretty close to nobody got out of these alive or untouched by serious "side effects," but the drug went on to more studies, and more deaths, in the U.S.

Newer drugs -- after AZT -- cause liver failure, which is now the major cause of death among AIDS patients.

And now you know about that, too.

Look into "ACTG 076" for information about AZT studies on children. Two versions of these trials exist: the story about the studies being terminated because the drug's effects were so miraculous, and the other one about the studies ending when people pulled their kids out because they didn't want them to die. Harlem, South Bronx, the usual people.

Happy "AIDS Awareness Month."

Thursday, December 7, 2006 10:32 AM

Consent

Consent is largely influenced by social and economic factors. Many people in developing countries consent to clinical trials because doing so is the only possible way to access necessary drugs kept at out of reach prices by big pharma. The same thing happens in the US, where health is also a commodity. Desperate people consent to all sorts of things that aren't ethical.

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